Study to Assess Allogeneic Anti-CD38 A2 Dimeric Antigen Receptor T Cells in Relapsed or Refractory Multiple Myeloma

Summary

This is a phase 1b, open-label, dose-escalation study of STI-1492 administered by a single intravenous infusion in subjects with relapsed or refractory multiple myeloma.

Eligibility

Inclusion Criteria:

* Must have relapsed or refractory multiple myeloma (RRMM) after having received prior lines of anti-myeloma treatments.
* Measurable disease as defined by one of the following: abnormal serum or M-protein levels; abnormal serum free light chain (FLC) assay; ≥ 30% clonal plasma cells in the bone marrow aspirate or biopsy sample
* Evidence of cell membrane CD38 expression as determined by immunohistochemistry (IHC) analysis ofbone marrow biopsy or extramedullary plasmacytoma
* Pulse oximetry ≥ 92% on room air
* Have a life expectancy ≥ 12 weeks
* Be willing and able to comply with the study schedule and all study requirements
* Willing to follow contraception guidelines

Exclusion Criteria:

* Previous treatment with any systemic therapy for multiple myeloma within 14 days prior to start of study dose
* Treatment with any cellular therapy within 8 weeks prior to start of study dose
* Have any unresolved toxicity ≥ Grade 2 from previous anticancer therapies
* A history of brain metastasis or spinal cord compression
* Has an ECOG performance status (PS) ≥ 3
* Has received allogeneic hematopoietic stem cell transplantation (HSCT) within 6 months, has active graft-versus-host disease (GvHD) following transplant, or is currently receiving immunosuppressive therapy following transplant
* Has any clinically significant low baseline lab results for hemoglobin, platelet counts, and neutrophil counts at screening unless resulting from underlying RRMM
* Has any clinically significant elevated baseline lab results for serum creatinine, AST or β2 microglobulin
* Abnormal INR or aPTT, unless on a stable dose of an anticoagulant
* Has known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C
* Is currently pregnant or breast feeding or planning on either during the study.
* Has an active bacterial, viral, or fungal infection
* Has active plasma cell leukemia
* Has extramedullary plasmacytoma(s)
* Has any significant medical condition, abnormality, or psychiatric illness that would prevent study participation
* Has left ventricular ejection fraction (LVEF) \< 40%
* Has second primary malignancies (SPMs) in addition to multiple myeloma if the SPM has required therapy within the last 3 years or is not in complete remission
* Has any additional clinical history of the CNS or cardiovascular disease that would place the patient at an unacceptable risk if the patient participates in the study

Conditions2

Locations3 sites

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